Cold atmospheric plasma plus endovascular treatment for diabetic foot ulcers with blocked lower‑leg arteries

Efficacy and Safety of Cold Atmospheric Plasma Combined With Endovascular Intervention in Patients With Diabetic Foot Ulcers and Lower Extremity Arterial Occlusion: a Randomized, Double-blind, Placebo-controlled Clinical Trial

This will test whether adding cold atmospheric plasma after successful endovascular angioplasty helps heal diabetic foot ulcers in adults with lower‑leg arterial blockages.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 86 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shenyang Medical College (Academic / other)
• Locations: 1 site (Anshan, Liaoning)
• Trial ID: NCT07073040 on ClinicalTrials.gov

What this trial studies

This interventional study enrolls adults with diabetes who have chronic foot ulcers and documented infrapopliteal arterial stenosis or occlusion who undergo successful infrapopliteal balloon angioplasty. After confirming arterial patency by intraoperative angiography, participants receive either cold atmospheric plasma treatment to the ulcer or a sham procedure in addition to standard wound care. The goal is to determine whether the local application of cold atmospheric plasma improves microvascular perfusion and accelerates wound healing beyond revascularization alone. Outcomes will include wound healing measures and safety endpoints over a defined follow‑up period.

Who should consider this trial

Good fit: Adults aged 18–80 with type 1 or 2 diabetes, an HbA1c ≤10%, a chronic foot ulcer (≥3 weeks) classified as Wagner‑Armstrong 1D or 2D, documented infrapopliteal stenosis/occlusion who have received successful infrapopliteal balloon angioplasty, and who provide informed consent are ideal candidates.

Not a fit: Patients receiving other local advanced wound therapies (for example vacuum‑assisted closure or maggot therapy), those who do not achieve successful revascularization, or those with wounds unsuitable for topical CAP application are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combined approach could speed ulcer healing, reduce the need for amputations, and improve limb salvage in people with ischemic diabetic foot ulcers.

How similar studies have performed: Small pilot studies and early clinical reports suggest cold atmospheric plasma can promote wound healing, but combining CAP with endovascular revascularization is a relatively novel approach without large randomized trial confirmation.

Eligibility criteria

Inclusion Criteria:

* Aged 18-80 years, with a diagnosis of type 1 or type 2 diabetes and diabetic foot ulcer; glycated hemoglobin (HbA1c) ≤ 10%.
* Presence of at least one chronic foot ulcer persisting for at least three weeks, with no signs of healing after standard-of-care treatment based on current clinical guidelines. The ulcer must be classified as Wagner-Armstrong grade 1D or 2D (Wagner: superficial ulcer \[grade 1\] or ulcer extending to tendon \[grade 2\]; Armstrong: presence of both ischaemia and infection \[stage D\]).
* Documented infrapopliteal arterial stenosis or occlusion by vascular ultrasound and/or CT angiography (CTA), meeting indications for revascularization. All enrolled patients must have received successful infrapopliteal balloon angioplasty, with intraoperative angiography confirming target artery patency.
* Provision of written informed consent.

Exclusion Criteria:

* Concurrent treatment of the wound with local vacuum therapy or maggot therapy.
* Undergoing dialysis.
* Use of local active antibiotics.
* Treatment with platelet-rich fibrin.
* Women of childbearing potential without effective contraception, or women who are actively breastfeeding.
* Presence of other severe organ dysfunction, with an expected survival of less than six months.
* Participation in another clinical trial within the past three months or currently enrolled in another clinical trial.

Where this trial is running

Anshan, Liaoning

• Ansteel General Hospital — Anshan, Liaoning, China (Recruiting)

Study contacts

• Principal investigator: Lin Tao, MM — Shenyang Medical College
• Study coordinator: Yun-En Liu, MD

Conditions Diabetic Foot Ulcers; Lower Extremity Arterial Occlusion; cold atmospheric plasma; diabetic foot ulcers; lower extremity arterial occlusion